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OpenTrials
Completed

NCT Number: NCT01889576

The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients.

The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation.

The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation.

The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.

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Key information

Conditions

Glucose Metabolism After Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplantation recipients
  • > 18 years of age
  • Less than 2 weeks post-transplantation
  • Hypomagnesemia < 1,7 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter).

Exclusion criteria

  • Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
  • Serum creatinine > 3 milligram/deciliter
  • Active infection (C reactive protein > 3 milligram/deciliter)
  • Severe hypomagnesemia (< 1,2 milligram/deciliter)
  • Hypokalemia (< 3,5 milli-equivalent/liter)
  • Severe hypocalcemia (< 6,5 milligram/deciliter)

Treatment and study plan

Magnesium oxide

Dietary Supplement

Primary outcomes

  1. Fasting glycemia, 3 months after transplantation.

    Time frame: 3 months after transplantation.

Secondary outcomes

  1. Incidence of diabetes after transplantation the first 3 months after transplantation.

    Time frame: 3 months after transplantation.

  2. Incidence of impaired fasting glucose the first 3 months after transplantation.

    Time frame: 3 months after transplantation.

  3. Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.

    Time frame: 3 months after transplantation.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2013
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.